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Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria (DHART)

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ClinicalTrials.gov Identifier: NCT02092766
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : June 1, 2015
Sponsor:
Collaborator:
Kinshasa School of Public Health
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
Delayed anaemia has been reported in European travellers with malaria cured by artesunate. Although no deaths related to this delayed anaemia have been reported so far, blood transfusion has been necessary in some affected patients. Recent observations suggest that this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess the incidence of late onset anaemia after treatment with intravenous artesunate compared to intravenous quinine, to identify patients at risk and to clarify the causes of this delayed anaemia.

Condition or disease Intervention/treatment Phase
Anaemia Drug: artesunate Drug: quinine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria
Study Start Date : June 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Malaria

Arm Intervention/treatment
Experimental: IV artesunate
Intravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total)
Drug: artesunate
Active Comparator: IV quinine
Intravenous quinine dihydrochloride 20 mg salt/kg body weight loading dose over 4 hours, then 10 mg/kg over 2 hours 8 hourly until 72 hours (9 doses total)
Drug: quinine



Primary Outcome Measures :
  1. Late onset anaemia [ Time Frame: Patients are hospitalized for 4 days or longer if still unwell. After discharge the follow-up consists of 6 weekly visits (time frame 42 days). Late anaemia is measured between 7 and 42 days following the start of antimalarial treatment ]
    Late onset anaemia in this study is defined as a ≥10% drop in haemoglobin on any previous measurement anytime between day 7 and 42



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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 6 months and ≤ 14 years
  • Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or mixed with non-falciparum species
  • Asexual P. falciparum parasitaemia ≥ 100,000/uL and ≤500,000/uL
  • Haemoglobin ≥5.0 g/dL
  • Parents/guardians agree to hospitalize the child for the length of treatment (3 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42
  • Signed consent from the guardian/parents

Exclusion Criteria:

  • Body weight ≤ 5 kg
  • Severe malaria or signs of severe malaria as defined by WHO Guidelines 2013
  • History of hypersensitivity or contraindication to quinine or artesunate
  • A clear history of adequate antimalarial treatment in the preceding 24 hours with drugs expected to be effective
  • Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the patient treatment or results of the study
  • Participation in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092766


Locations
Congo, The Democratic Republic of the
Kinshasa School of Public Health
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
University of Oxford
Kinshasa School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02092766     History of Changes
Other Study ID Numbers: KIMORU005
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by University of Oxford:
malaria
anaemia
artesunate

Additional relevant MeSH terms:
Anemia
Malaria
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Quinine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents